Method and assembly for fluid transfer and drug containment in an infusion system

ABSTRACT

A fluid transfer assembly, drug container, and method for enabling fluid transfer in an infusion system is taught. The assembly includes a fluid container containing an infusion fluid, and a drug container. The fluid container has at least one inlet port for receiving a medical substance from the drug container. The assembly further includes at least one fluid barrier controlling fluid passage between the drug container and the fluid container. The inlet port exhibits a first luer-lock connector, and the drug container is sealed by a cap exhibiting a second luer-lock connector for attachment to the first luer-lock connector. The fluid barrier is designed and arranged to be ruptured by an external force to allow the fluid passage.

CROSS-REFERENCE TO RELATED APPLICATIONS

This Application is a divisional of U.S. patent application Ser. No.10/063,159 filed Mar. 26, 2002, now allowed, the disclosure of which ishereby incorporated by reference in its entirety.

BACKGROUND OF INVENTION

Technical Field

The present invention relates to a fluid transfer assembly for use in aninfusion system, including a fluid container containing an infusionfluid, and a drug container containing a medical substance, wherein thefluid container has at least one inlet port for receiving the medicalsubstance from the drug container and the assembly further includes atleast one fluid barrier controlling fluid passage between the drugcontainer arid the fluid container. The invention also relates to a drugcontainer for use in the infusion system, and to a method for enablingfluid transfer in the infusion system.

Background Information

A serious problem in connection with drug preparation, drugadministration and other similar handling is the risk that medical andpharmacological staff are exposed to drugs or solvents which mightescape into the ambient air. This problem Is particularly serious whencytotoxins, antiviral drugs, antibiotics and radiopharmaceuticals areconcerned.

For this reason, there has been a need of safer systems for handling andadministrating drugs and other medical substances.

Accordingly, U.S. Pat. No. 4,564,054 discloses a fluid transfer devicefor transferring a substance from one vessel to another vessel avoidingleakage of liquid and gas contaminants. The disclosed device comprises afirst member designed as a hollow sleeve and having a piercing memberprovided with a passageway. The piercing member is attached to the firstmember which has a first barrier member at one end just opposite the tipof the piercing member. Thereby, the piercing member can be passed andretracted through the first barrier member which seals one end of thefirst member. The fluid transfer device further comprises a secondmember which is attached to or attachable to one of the vessels or tomeans arranged to communicate therewith. The second member has a secondbarrier member, and mating connection means arranged on the first andsecond members for providing a releasable locking of the members withrespect to each other. The barrier members are liquid and gas-proofsealing members which seal tightly after penetration and retraction ofthe piercing member and prevent leakage of liquid as well as gascontaminants. In the connected position of the first and second members,the barrier members are located in such a way with respect to each otherthat the piercing member can be passed there through.

According to U.S. Pat. No. 4,564,054, the above-mentioned piercingmember is a needle arranged for puncturing the first and the secondbarrier members, wherein the end opposite to the one end of the firstmember has means for sealingly receiving or being permanently attachedto an injection syringe or the like for withdrawing and/or addingsubstance to the vessel attached to the second member. When attached tothe first member, the injection syringe or the like communicates withthe passageway of the needle, so that in the retracted position theneedle is hermetically enclosed in the first member having the injectionsyringe or the like connected thereto.

International Patent Publication No. WO 99/27886 to Fowles et al.discloses a connector device intended for establishing fluidcommunication between a first container and a second container. Theconnector device comprises a first sleeve member having a first and asecond end, wherein the first sleeve member has a first attaching memberat the first end which is adapted to attach to the first container. Theconnector device further comprises a second sleeve member which has afirst end and a second end. Thereby, the second sleeve member isassociated to the first sleeve member and movable with respect theretofrom an inactivated position to an activated position, wherein thesecond sleeve member has a second attaching member at the second endadapted to attach the second sleeve member to the second container.According to WO 99/27886, the connector device further comprises a firstand second piercing member projecting from one of the first and secondsleeve members for providing a fluid flow path from the first containerto the second container, and means for Independently hermeticallysealing the first and second members.

Furthermore, U.S. Pat. No. 6,258,078 discloses a luer connector whichfacilitates connection of a hypodermic syringe to a vial, comprising aluer connectable to a syringe and which extends to a sharpened endcapable of being driven through a puncturable vial closure to therebypuncture the closure, a luer support mountable on a vial, and whichinitially supports the luer in a first position in which the sharpenedend of the conduit Is pointed towards the closure, and a luer driversuch that movement of the driver relative to the support causes the luerto be driven so that the sharpened end punctures the closure and entersthe vial.

When performing infusion, it is often necessary to Inject a drug orother medical substance into the infusion fluid inside an infusion bagor other infusion fluid container. This is normally done by means ofpenetrating a septum or another fluid barrier of an injection port onthe infusion bag or the infusion fluid line with a hypodermic needle ofa syringe filled with the medical fluid in question.

However, it has been found that the use of regular syringes or otherdrug containers according to prior art when injecting hazardoussubstances such as cytotoxins into an infusion bag or another infusionfluid container might cause pollution of the working environment,something which of course Is unacceptable. For this reason, there is aneed of an improved device which eliminates the risk that potentiallyhealth-hazardous substances escape into the ambient air or workingenvironment when injecting a drug or another medical substance into aninfusion system.

Furthermore, there is a strong need of reducing the costs for medicaltreatment such as infusion treatment. One way of reducing the costswould be to reduce the number of medical device components which areneeded for introducing medical substances into the infusion system, andwhich have to be kept in stock at hospitals which perform such infusiontreatment.

SUMMARY OF INVENTION

Accordingly, a first object of the present invention is to provide avery simple, reliable and safe fluid transfer assembly for use in aninfusion system, which assembly allows the administration of a medicalsubstance to a patient using a minimum of medical device components.This first object is achieved by means of a fluid transfer assemblyincluding a fluid container containing an infusion fluid, and a drugcontainer containing a medical substance, wherein the fluid containerhas at least one inlet port for receiving the medical substance from thedrug container, and the assembly further includes at least one fluidbarrier controlling fluid passage between the drug container and thefluid container. Thereby, the inlet port exhibits a first luer-lockconnector, and the drug container is sealed by a cap exhibiting a secondluer-lock connector for attachment to the first luer-lock connector,wherein the fluid barrier is designed and arranged to be ruptured by anexternal force to allow the fluid passage.

A second object of the present invention is to provide a drug containerfor use in the assembly according to the invention. This second objectis achieved by means of a drug container containing a fixed dose of amedical substance, wherein the drug container is sealed by a capexhibiting a luer-lock connector for attachment to a correspondingconnector provided on an Inlet port of a container for infusion fluid Inorder to create a luer-lock coupling.

A third object of the present invention is to provide a method forenabling fluid transfer in an Infusion system including the assemblyaccording to the invention. This third object is achieved by means of amethod which includes to provide a fluid container containing aninfusion fluid and a drug container containing a medical substance,wherein the fluid container has at least one inlet port for receivingthe medical substance from the drug container, and the method furtherincludes to provide the infusion system with at least one fluid barriercontrolling fluid passage between the drug container and the fluidcontainer. Thereby, the method further Includes to provide the fluidcontainer with a first luer-connector on the inlet port, to provide thedrug container with a cap exhibiting a second luer-lock connector, andto attach the first luer-lock connector to the second luer-lockconnector by means of a luer-lock coupling. Furthermore, the methodincludes to apply an external force onto said fluid barrier to open thefluid passage, to create a positive pressure inside the fluid container,to transfer at least part of the positive pressure to the drug containervia the fluid passage, and to remove the positive pressure from thefluid container In order to initiate transfer of the medical substancefrom the drug container to the fluid container.

Further objects of the present invention will become evident from thefollowing description, and the features enabling these further objectsto be achieved are listed in the dependent claims.

BRIEF DESCRIPTION OF DRAWINGS

In the following, the present invention will be described in greaterdetail with reference to the attached drawings, in which:

FIG. 1 is a perspective view illustrating both a preferred embodimentand an alternative embodiment of a fluid transfer assembly according tothe invention,

FIG. 2 is a perspective view of a drug container according to apreferred embodiment of the invention,

FIG. 3 is a perspective view of a drug container according to analternative embodiment of the invention,

FIG. 4 is a perspective view of a drug container according to anotheralternative embodiment of the invention, and

FIG. 5 is perspective view of an alternative embodiment of a fluidtransfer assembly according to the invention.

DETAILED DESCRIPTION

In the following, a preferred embodiment and a number of alternativeembodiments of the assembly according to the invention will be describedin greater detail with reference to the attached FIGS. 1-5.

The fluid transfer assembly according to the invention is intended foruse in an infusion system of the type where it might become necessary tointroduce a medical substance, such as a drug, cytotoxin or anantibiotic, into an infusion fluid, such as a saline solution.

As is evident from FIG. 1, the assembly 100 includes a fluid container101 containing an infusion fluid 102 and a drug container 103, 203containing a medical substance 104, 204.

Preferably, the fluid container 101 is a flexible bag made of a plasticfilm which exhibits suitable properties for the application. The fluidcontainer 101 has at least one inlet port 105, 106 for receiving themedical substance 104, 204 from the drug container 103, 203. Theassembly further includes at least one fluid barrier 107, 108controlling fluid passage between the drug container 103, 203 and thefluid container 101.

It should be noted that FIG. 1 illustrates both preferred (e.g.,reference numerals 101, 105 and 103) and alternative embodiments (e.g.,reference numerals 101, 106 and 203) of the fluid transfer assemblyaccording to the invention. Accordingly, in real life, only one of theports, e.g., the one denoted 105, would act as an inlet port forreceiving the medical substance from the drug container 103, whereas theother port 106 would act as an outlet port for a mixture of the infusionfluid and the introduced medical substance. Alternatively, the portdenoted 106 in FIG. 1 could act as an inlet port for medical substancefrom the drug container 203, while the port denoted 105 could act as anoutlet port to which an infusion line can be connected.

Different types of inlet ports are known per se. An inlet port accordingto prior art usually exhibits a septum acting as a fluid barrier. Such aseptum according to the prior art is intended to be penetrated by apiercing member such as a hypodermic needle of a syringe containing themedical substance which is to be administrated.

According to the invention, however, the inlet port 105, 106 includes afirst luer connector 110, 111. The function of male/female luer-lockconnectors is well known per se, but for other uses than in the assemblyaccording to the invention.

According to the invention, the drug container 103, 203 is sealed by acap 112, 212 including a second luer-lock connector 113, 213 forattachment to the first luer-connector 110, 111. This feature of thepresent invention enables the drug container 103, 203 to be attached tothe infusion fluid container 101 in a very simple, fast and safe way.

Furthermore, according to the invention, the fluid barrier 107, 109, 108is designed and arranged to be ruptured by an external force to allowthe fluid passage from the drug container to the fluid container, orvice versa. This feature ensures that no premature fluid communicationtakes place between the drug container and the fluid container.

In one advantageous embodiment of the fluid transfer assembly accordingto the invention, the inlet port 105, 106 forms a first fluid ductbetween the fluid container 101 and the first luer-lock connector 110,111, wherein the fluid barrier 107, 108 is provided inside this firstfluid duct.

In another advantageous embodiment, the cap 112 of the drug container103 includes a protruding member 114 which forms a second fluid ductbetween the drug container 103 and the second luer-lock connector 113,wherein the fluid barrier 109 is provided inside the second fluid duct.

In a preferred embodiment of the assembly according to the invention,the inlet port 105 forms a first fluid duct between the fluid container101 and the first luerconnector 110. Furthermore, the cap 112 includes aprotruding member 114 which forms a second fluid duct between the drugcontainer 103 and the second luer-lock connector 113, wherein fluidbarriers 107, 109 are provided both inside the first and the secondfluid ducts. This feature provide full control over the fluidcommunication between the drug container and fluid container, andensures that no accidental fluid transfer can take place.

In an alternative embodiment of the fluid transfer assembly according tothe invention, the second luer-lock connector 213 is attached directlyto the cap 212. Even more advantageously, as illustrated in FIG. 3, thesecond luer-lock connector 213 is an integral part of the cap 212. Inorder to prevent contamination, as indicated in FIG. 2, and in theembodiment in FIG. 3, also in order to seal the drug container, thesecond luer-lock connector 113, 213 preferably is protected by aremovable closure 126, 226 or a protective lid, or alternatively apierceable closure, before use.

In the alternative embodiment of the assembly, the drug container 203preferably includes a neck 215 as indicated in FIG. 3, wherein the cap212 includes locking members 216 for grasping the neck 215. Even moreadvantageously, the drug container also includes an opening sealed by aclosure 217, wherein the cap 212 includes a hollow needle 218 forpenetrating the closure 217. The alternative embodiment enables the useof conventional drug vials in the assembly according to the invention,something which might be advantageous for practical reasons.

In a preferred embodiment of the fluid transfer assembly as shown inFIGS. 1 and 2, the drug container 103 includes a neck 115, wherein thecap 112 includes a protruding member 114 which is attached to the neck115 by means of an annular capsule member 121. The capsule-likeattachment makes it possible modify a fairly conventional drugvial-filling line to produce drug containers for use in the fluidtransfer assembly according to the invention. However, within the scopeof the invention, it is also conceivable with embodiments where aprotruding member is attached to the drug container by means of anothersuitable permanent attachment.

In another advantageous embodiment of the fluid transfer assemblyaccording to the invention, as illustrated in FIG. 4, the drug container303 includes a neck 315, and the cap 312 includes a protruding member314 that forms a second fluid duct between the drug container 303 andthe second luer-lock connector 313. In this embodiment the cap 312further includes locking members 316 for grasping the neck 315. Thelocking members 316 enable drug vials of a conventional design to beused in the fluid transfer assembly, whereas the protruding member 314makes it easier to control the fluid passage between the fluid containerin question and the drug container 303, or vice versa.

In a preferred embodiment of the fluid transfer assembly as indicated inFIGS. 1 and 2, the fluid barrier is made of a brittle polymer member107, 109, 108 which can be divided along a weakening line by means ofthe external force. However, within the scope of the invention, it isconceivable with many different designs of the fluid barrier, as long asthe barrier provides a safe sealing of the fluid container and/or thedrug container, and as long as it is possible for an operator toeliminate the sealing action by means of applying an external force ontothe fluid barrier in order to break, rupture, puncture, or dislocate thefluid barrier and open a fluid passage through the barrier.

In another embodiment of the fluid transfer assembly, the walls 119 ofthe inlet port 105 are made of a flexible material and form a firstfluid duct between the fluid container 101 and the first luer-lockconnector 110. In this embodiment, in order to provide improved controlof the fluid passage, the fluid transfer assembly 100 further includes afirst clamping member 127 for compressing the walls 119, closing thefirst fluid duct and preventing undesired fluid passage between thefluid container 101 and the first luer-lock connector 110. Thisembodiment is particularly valuable after having transferred the entirefixed dose of medical substance from the drug container into theinfusion fluid container, since it prevents fluid from returning intothe drug container.

Alternatively, as illustrated in FIG. 5, the cap 312 of the drugcontainer includes a protruding member 314 which forms a second fluidduct between the drug container 303 and the second luer-lock connector313. The fluid transfer assembly 300 includes a second clamping member328 for compressing the protruding member 314, thereby closing thesecond fluid duct and preventing undesired fluid passage between thesecond luer-lock connector 313 and the drug container 303.

In another alternative embodiment as illustrated in FIG. 5, the fluidcontainer 301 includes a protruding, resilient tube 322. The firstluer-lock connector 310 of the inlet port 305 is provided on a hollowspike member 323 designed and arranged to be firmly retained inside thetube 322. This embodiment enables conventional infusion bags to beutilized in the fluid transfer assembly according to the invention.

In still another alternative embodiment of the fluid transfer assembly,in addition to the first luer-lock connector 310, the inlet port 305also includes an infusion line 325 attached thereto. The fluid transferassembly 300 also includes a third clamping member 329 for compressingthe infusion line 325, thereby preventing undesired fluid passage therethrough. This embodiment makes it possible to prevent accidental passageof medical substance into the infusion line while transferring themedical substance from the drug container into the infusion fluidcontainer.

In the preferred embodiment of the fluid transfer assembly according tothe invention, the inlet port 105, 106 forms a first fluid duct betweenthe fluid container 101 and the first luer-lock connector 110, 111,wherein the fluid barrier 107, 108 is provided inside the first fluidduct. Furthermore, the fluid container 101 is flexible and made of afirst polymer material, the first fluid duct is formed by walls 119, 120made of a second polymer material, the first luer-lock connector 110,111 is made of a third polymer material, and the fluid barrier 107, 108is made of a fourth polymer material. As such, the first 101 and second119, 120 polymer materials are more flexible than the third 110, 111polymer material, and the fourth polymer material 107, 108 is morebrittle than all of the first 101, second 119, 120 and third 110, 111polymer materials. This preferred choice of materials ensures that theaction of the fluid barrier 107 (and 108) between the fluid containerand the first luer-lock connector can be eliminated without accidentallybreaking other components of the fluid transfer assembly according tothe invention.

In a preferred embodiment, the cap 112 includes a protruding member 114that forms a second fluid duct between the drug container 103 and thesecond luer-lock connector 113, wherein the fluid barrier 109 isprovided inside the second fluid duct. The drug container 103 is made ofa rigid material, the protruding member 114 is made of a more flexiblematerial than the second luer-lock connector 113 and the drug container103, and the fluid barrier 109 is made of a more brittle material thanthe drug container 103, the protruding portion 114, and the secondluer-lock connector 113. In a corresponding way as described above, thispreferred choice of materials ensures that the fluid barrier 109 betweenthe drug container and the second luer-lock connector can be eliminatedwithout accidentally breaking any other components of the fluid transferassembly according to the invention.

In the preferred embodiment of the fluid transfer according to theinvention, the drug container 103, 203 is made of glass. However, withinthe scope of the invention, it also conceivable with embodiments wherethe drug container is made of other suitable materials, e.g., a rigidpolymer material, as long as those material have sufficient chemicalresistance and otherwise are suitable from a medical point of view.

In the following, a preferred embodiment and a number of alternativeembodiments of a drug container according to the invention will bedescribed in greater detail with particular reference to FIGS. 2, 3 and4.

The drug container is intended for use in an infusion system including afluid transfer assembly according to the invention.

The drug container 103, 203, 303 contains a fixed dose of a medicalsubstance 104, 204, 304. In this context, “fixed dose” means that thequantity of medical substance is intended to be transferred to theinfusion fluid container in question in its entirety, and that a drugcontainer containing the desired quantity of medical substance has to beselected before administration. The medical substance can be providedeither in a fluid state, or advantageously, in the form of a dry powderthat is dissolved into a small quantity of infusion fluid from the fluidcontainer connected to the drug container, forming a drug solution whichis returned to the infusion fluid container.

According to the invention, the drug container 103, 203, 303 is sealedby a cap 112, 212, 312 exhibiting a luer-lock connector 113, 213, 313for attachment to a corresponding connector provided on an inlet port ofa container for infusion fluid in order to create a luer-lock coupling.This feature enables the drug container to be utilized in a fluidtransfer assembly according to the invention. The luer-lock connector ofthe drug container is preferably a male luer-lock connector when it isintended to interact with an inlet port of a fluid container providedwith a female luer-lock connector. In case the drug container isintended to interact with an inlet port exhibiting a male luer-lockconnector, it will of course have to exhibit a female luer-lockconnector.

In a preferred embodiment of the drug container, the cap 112 includes aprotruding member 114 that forms a fluid duct between the drug container103 and the second luer-lock connector 113. In doing so, a fluid barrier109 designed and arranged to be ruptured by means of an external forceis provided inside the second fluid duct. Preferably, the fluid barrieris designed and arranged to be ruptured by means of an external forceexerted by a person by hand. This is also the case with the other fluidbarriers included in the fluid transfer assembly according to theinvention.

In a preferred embodiment, the drug container 103 includes a neck 115.The cap 112 includes a protruding member 114 attached to the neck 115 bymeans of an annular capsule member 121. However, as mentioned above,other embodiments are conceivable where the protruding member ispermanently attached to the drug container in another suitable way.

In another advantageous embodiment as illustrated in FIG. 4, the drugcontainer 303 includes a neck 315, and the cap 312 includes a protrudingmember 314 that forms a second fluid duct between the drug container 303and the second luer-lock connector 313. The cap 312 further includeslocking members 316 for grasping the neck 315. This embodiment enablesthe cap to be permanently attached to a drug vial of a conventionaldesign. Furthermore, the protruding member improves control of the fluidpassage out from or into the drug container, since a suitable fluidbarrier can be arranged inside the second fluid duct, or the secondfluid duct can be blocked or opened by means of applying or removing anexternal pressure, e.g., as indicated in FIG. 5, by means of a suitabledamping member 328 of a type well known per se.

In a preferred embodiment of the drug container as illustrated in FIG.2, the protruding member 114 encircles a fluid barrier made of a brittlepolymer member 109 that can be divided along a weakening line by meansof an external force.

In the preferred embodiment, the protruding member 114 forms a fluidduct between the drug container 103 and the luer-lock connector 113,wherein the fluid barrier 109 is provided inside the fluid duct. Thedrug container 103 is made of a rigid material, the protruding member114 is made of a more flexible material than the luer-lock connector113, and the drug container 103, and the fluid barrier 109 is made of amore brittle material than the drug container 103, the protrudingportion 114, and the luer-lock connector 113.

In an alternative embodiment of the drug container according to theinvention, as illustrated in FIG. 3, the luer-lock connector 213 isattached directly to the cap 212. Advantageously, the luer-lockconnector 213 is an integral part of the cap 212. The second luer-lockconnector 213 is preferably protected by a removable or pierceableclosure 226.

In the alternative embodiment, the drug container 203 advantageouslyincludes a neck 215, wherein the cap 212 includes locking members 216for grasping the neck 215.

Even more advantageously, the drug container 203 in the alternativeembodiment exhibits an opening sealed by a closure 217, wherein the cap212 exhibits a hollow needle 218 for penetrating the closure 217.

Preferably, the drug container 103, 203 according to the invention ismade of glass. However, it is also conceivable with embodiments wherethe drug container is made of another material, e.g., a suitable rigidpolymer material.

In the following, a preferred embodiment and a number of alternativeembodiments of a method according to the invention will be described ingreater detail, whenever applicable with reference to the attached FIGS.1-5.

The method is intended for enabling fluid transfer in an infusion systemutilizing the fluid transfer assembly according to the invention.

The method includes providing a fluid container 101 containing aninfusion fluid 102 and a drug container 103, 203 containing a medicalsubstance 104, 204. The fluid container 101 has at least one inlet port105, 106 for receiving the medical substance 104, 204 from the drugcontainer 103, 203. The method further includes providing the infusionsystem with at least one fluid barrier 107, 108 controlling fluidpassage between the drug container 103, 203 and the fluid container 101.

The method according to the invention further includes providing thefluid container 101 with a first luer-lock connector 110, 111 on theinlet port 105, 106, providing the drug container 103, 203 with a cap112, 212 exhibiting a second luer-connector 113, 213, attaching thefirst luer-lock connector 110, 111 to the second luer-lock connector113, 213 by means of a luer-lock coupling, applying an external forceonto the fluid barrier 107, 109, 108 to open the fluid passage, andcreating a positive pressure inside the fluid container 101. Accordingto the invention the method also includes transferring at least part ofthe positive pressure to the drug container 103, 203 via the fluidpassage, and removing the positive pressure from the fluid container 101in order to initiate transfer of the medical substance 104, 204 from thedrug container 103, 203 to the fluid container 101.

In a preferred embodiment, the method further includes rupturing thefluid barrier 107, 108 by means of twisting, bending, or squeezingmaterial portions 119, 120 between the fluid container 101 and the firstluer-lock connector 110, 111.

Preferably, the method also includes rupturing another fluid barrier bymeans of twisting, bending or squeezing material portions 114 betweenthe drug container 103 and the second luer-lock connector 113.

Particularly advantageously, the method further includes providing thedrug container 103 with a neck 115, providing the cap 112 with aprotruding member 114, providing an annular capsule member 121, andattaching the protruding member 114 to the neck 115 by means of theannular capsule member 121 in a drug container filling line.

Preferably, the method further includes providing the fluid barrier inthe form of a brittle polymer member 107, 109, 108 exhibiting at leastone weakening line, and dividing the brittle polymer member 107, 109,108 along the weakening line by means of the external force.

In the preferred embodiment, the method further includes making thefluid container 101 of a flexible first polymer material, forming walls119, 120 of a second polymer material into a first fluid duct betweenthe fluid container 101 and the first luer-lock connector 110, 111,making the first luer-lock connector 110, 111 of a third polymermaterial, and making the fluid barrier 107, 108 of a fourth polymermaterial. Thereby, the method further includes arranging the fluidbarrier 107, 108 inside the first fluid duct, selecting the first 101and second 119, 120 polymer materials to be more flexible than the third110, 111 polymer material, and selecting the fourth polymer material107, 108 to be more brittle than all of the first 101, second 119, 120and third 110, 111 polymer materials.

Preferably, the method further includes making the drug container 103 ofa rigid material, including a protruding member 114 on the cap 112 inorder to form a second fluid duct between the drug container 103 and thesecond luer-lock connector 113, and accommodating the fluid barrier 109inside the second fluid duct. Thereby, the method also includesselecting a more flexible material for the protruding member 114 thanfor the second luer-lock connector 113 and the drug container 103, andselecting a more brittle material for the fluid barrier 109 than for thedrug container 103, the protruding portion 114, and the second luer-lockconnector 113.

In an alternative embodiment of the invention, the method furtherincludes providing the drug container 203 with a neck 215, providing thecap 212 with locking members 216, and causing the locking members 216 tograsp the neck 215, thereby attaching the cap 212 permanently to thedrug container 203.

In the alternative embodiment, the method advantageously also includesproviding the drug container 203 with an opening sealed by a closure217, providing the cap 212 with a hollow needle 218, and causing thehollow needle 218 to penetrate the closure 217.

Preferably, the method further includes protecting the second luer-lockconnector 213 by means of a removable closure 226, and removing theclosure before attaching the second luer-lock connector 213 to the firstluer-lock connector 111. Alternatively, the method further includesprotecting the second luer-lock connector 213 by means of a pierceableclosure 226, and piercing the closure 226 when attaching the secondluer-lock connector 213 to the first luer-lock connector 111. This, ofcourse, requires that the pierceable closure is made of material whichwill not release any loose particles into the luer-lock coupling or thefluid passage. The skilled person, having read this description, shouldbe able to find such a suitable material without any extensive work.

The method according to the invention preferably also includes to makethe drug container 103, 203 of glass or a rigid polymer material.

As used herein, the expression “drug container” refers to a containerfor medical substance which is leakage-proof and otherwise suitable forthe purpose in question. Preferably, the “drug container” utilized inthe assembly according to the invention has only one opening which issealed by a closure or cap, and is made of a solid, rigid and inflexiblematerial, such as glass or rigid polymer material. Furthermore, it ispreferred that the drug container has no displaceable bottom, flexiblewalls, or the like, which will prevent the creation of the positivepressure which is needed in order to empty the medical substance intothe infusion fluid in the interacting fluid container.

As used herein, the expression “permanent attachment” means that thecomponents in question, in their normal, intended use, cannot bedisengaged without the use of excessive force.

In the foregoing description, the present invention has been describedin connection with a few specific embodiments and with reference to theattached drawings. However, the present invention is by no meansstrictly confined to these embodiments or to what is shown in thedrawings, but the scope of the invention is defined in the followingclaims.

Accordingly, as illustrated in FIG. 1, the method according to theinvention can further include making the walls 119 of the inlet port 105of a flexible material, forming a first fluid duct between the fluidcontainer 101 and the first luer-lock connector 110 inside the flexiblematerial, and providing a first clamping member 127 for compressing thewalls 119, thereby closing the first fluid duct and preventingundesirable fluid passage between the fluid container 101 and the firstluer-lock connector 110.

In still another embodiment, illustrated in FIG. 5, the method caninclude providing the cap 312 with a protruding member 314 that forms asecond fluid duct between the drug container 303 and the secondluer-lock connector 313, and providing a second clamping member 328 forcompressing the protruding member 314, thereby closing the second fluidduct and preventing undesirable fluid passage between the secondluer-lock connector 313 and the drug container 303.

Furthermore, the method can also include providing the fluid container301 with a protruding, resilient tube 322, providing a hollow spikemember 323 for the first luer-lock connector 310, and inserting thehollow spike member 323 into the resilient tube 322, and/or attaching aninfusion line 325 to the inlet port 305, in addition to the firstluer-lock connector 310, and providing a third clamping member 329 forcompressing the infusion line 325, thereby preventing undesirable fluidpassage there through.

While only certain preferred embodiments of the invention have beenillustrated and described, it is realized that several variations andmodifications within the scope of the enclosed claims can occur.

What is claimed is:
 1. A fluid transfer assembly for use in an infusionsystem, said assembly comprising: a fluid container having an infusionfluid, a drug container having a medical substance, said fluid containerfurther comprising a first port for receiving said medical substancefrom said drug container, said drug container further comprising a capfor sealing said drug container, said first port further comprisingwalls being made of a flexible material, and the first port furthercomprises a first luer-lock connector, and wherein the walls form afirst fluid duct between said fluid container and said first luer-lockconnector, the first fluid duct having a first fluid barrier controllingfluid passage between said drug container and said fluid container, andsaid cap further comprising a second luer-lock connector for attachmentto said first luer-lock connector and a protruding member forming asecond fluid duct between said drug container and said second luer-lockconnector, the second fluid duct having a second fluid barrier, saidfluid container further comprising a second port having walls being madeof a flexible material, the second port adapted for connection to aninfusion line, the walls of the second port forming a third fluid ductbetween said fluid container and said infusion line, the third fluidduct having a third fluid barrier, wherein said first fluid barrier,second fluid barrier and third fluid barrier are designed and arrangedto be ruptured by an external twisting, bending, or squeezing force toallow said fluid passage, wherein said fluid container being flexibleand comprising a first polymer material, said first port and second portcomprising a second polymer material, said first luer-lock connectorcomprising a third polymer material, and said first fluid barrier,second fluid barrier and third fluid barrier comprising a fourth polymermaterial, wherein said first and second polymer materials are moreflexible than said third polymer material, and said fourth polymermaterial is more brittle than all of said first, second and thirdpolymer materials.
 2. The fluid transfer assembly according to claim 1,wherein the second luer-lock connector is attached directly to said cap.3. The fluid transfer assembly according to claim 1, wherein the secondluer-lock connector is an integral part of said cap.
 4. The fluidtransfer assembly according to claim 1, said second luer-lock connectorfurther comprising a removable closure for protection before use.
 5. Thefluid transfer assembly according to claim 1, said drug containerfurther comprising a neck, and said cap further comprising a protrudingmember attachable to said neck by an annular capsule member.
 6. Thefluid transfer assembly according to claim 1, said fluid transferassembly further comprising a first clamping member able to compresssaid walls forming said first fluid duct and preventing undesired fluidpassage between said fluid container and said first luer-lock connector.